EMEA Recommends a New Warning for Epoetins for Their Use in Cancer
Patients

LONDON, July 1, 2008-The European
Medicines Agency (EMEA) has recommended updating the product
information for epoetin-containing medicines with a new warning for
their use in cancer patients stating that blood transfusion should
be the preferred method of correcting anaemia in patients suffering
cancer.

Epoetin-containing medicines are
indicated in patients with chronic renal failure and for the
treatment of anaemia in symptomatic patients with non-myeloid
tumours receiving chemotherapy.

The Agency’s Committee for
Medicinal Products for Human Use (CHMP) had reviewed new data from
studies that showed an increased risk of tumour progression, venous
thromboembolism and shorter overall survival in cancer patients who
received epoetins compared to patients who did not receive them.
Following this review, the CHMP concluded, at its June 2008
meeting, that the benefits of epoetins continue to outweigh their
risks in the approved indications.

However, in cancer patients with a
reasonably long life-expectancy, the benefit of using epoetins does
not outweigh the risk of tumour progression and shorter overall
survival and therefore the Committee concluded that in these
patients anaemia should be corrected with blood
transfusions.

Doctors and patients are advised that
the decision to administer epoetin-containing medicines should be
based on an informed assessment of the benefits against the risks
on individual basis, taking into account the type and stage of
tumour, the degree of anaemia, the patient’s life-expectancy,
the environment in which the patient is being treated and patient
preference.

The Committee agreed that there is no
consequence of the new information on the use of epoetincontaining
medicines for the treatment of anaemia in patients with chronic
renal failure.

The Agency is closely monitoring the
safety of epoetin-containing medicines. In September 2007 a full
safety review of all epoetins was finalised. As a consequence, the
product information was updated and the indication for all the
epoetin-containing medicines was changed to state that epoetins
should be used in the treatment of anaemia only if associated with
symptoms such as weakness and lack of energy.

The CHMP will continue to review the
safety profile of the epoetins within the terms of their currently
authorised indications in the EU as additional data become
available.

The CHMP also requested that the
marketing authorisation holders for epoetin-containing medicines
should carry out, as a priority, additional studies to clarify the
risks and benefits of epoetins in the treatment of patients with
cancer under the new treatment recommendations.

-- ENDS –

*corr The information in the notes
concerning epoetin-containing medicines has been
corrected.

Notes: 1. More information is
available in a question-and-answer document.

2. Epoetin-containing medicines are
approved at the level of Member States. They may be authorised for
use in both cancer and kidney patients, or only in kidney patients:
Epoetin-containing medicines that can be used in both cancer and
kidney patients are: Eprex and Erypo (epoetin alfa), Aranesp and
Nespo (darbepoetin alfa), NeoRecormon (epoetin beta) and Retacrit
and Silapo (epoetin zeta).

2. Further information on the outcome
of the review of epoetins finalised in September 2007 can be found
here.

3. This press release, together with
other information on the work of the EMEA, can be found on the EMEA
website: www.emea.europa.eu Media enquiries only to: Martin Harvey
Allchurch or Monika Benstetter Tel. (44-20) 74 18 84 27, E-mail
press@emea.europa.eu

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